Sildenafil 50mg film-coated tablets
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
26-04-2024
Summary of Product characteristics
(SPC)
26-04-2024
Active ingredient:
Sildenafil
Available from:
Milpharm Limited
ATC code:
G04BE03
INN (International Name):
Sildenafil
Dosage:
50mg
Pharmaceutical form:
Film-coated tablets
Administration route:
Oral use
Units in package:
1, 2, 4, 8 & 12 film-coated tablets
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
APL Swift Services (Malta) Limited
Therapeutic group:
Urologicals; Drugs used in erectile dysfunction
Therapeutic indications:
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil to be effective, sexual stimulation is required.
Authorization status:
Authorised
Authorization date:
2013-08-12
Patient Information leaflet
SILDENAFIL 50 MG FILM-COATED TABLETS
SILDENAFIL 100 MG FILM-COATED TABLETS
Sildenafil
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sildenafil is and what it is used for
2.
What you need to know before you take Sildenafil
3.
How to take Sildenafil
4.
Possible side effects
5.
How to store Sildenafil
6.
Contents of the pack and other information
Sildenafil contains the active substance sildenafil which belongs to
a group of medicines called phosphodiesterase type 5 (PDE 5)
inhibitors. It works by helping to relax the blood vessels in your
penis, allowing blood to flow into your penis when you get sexually
excited. Sildenafil will only help you to get an erection if you are
sexually stimulated.
Sildenafil is a treatment for adult men with erectile dysfunction,
sometimes known as impotence. This is when a man cannot get, or
keep a hard, erect penis suitable for sexual activity.
DO NOT TAKE SILDENAFIL:
-
if you are allergic to sildenafil or any of the other ingredients of
this medicine (listed in section 6).
-
If you are taking medicines called nitrates, as the combination
may lead to a dangerous fall in your blood pressure. Tell your
doctor if you are taking any of these medicines which are often
given for relief of angina pectoris (or “chest pain”). If you
are
not certain, ask your doctor or pharmacist.
-
If you are using any of the medicines known as nitric oxide
donors such as amyl nitrite (“poppers
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sildenafil 50 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg Sildenafil (as
sildenafil citrate).
Excipient with known effect:
Each 50 mg film-coated tablet contains
3.7 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL
FORM
Film-coated tablet
White to off-white, round (9.6 mm diameter), biconvex film-coated
tablets debossed
with “SL” on one side and 50 on the other side.
4 CLINICAL
PARTICULARS
4.1 THERAPEUTIC
INDICATIONS
Treatment of men with erectile dysfunction, which is the
inability to achieve or
maintain a penile erection sufficient for satisfactory sexual
performance.
In order for Sildenafil to be effective, sexual stimulation
is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This strength is not suitable for dosages below 50 mg
Other medicinal products of Sildenafil in adequate strength
are available.
USE IN ADULTS
The recommended dose is 50mg taken as needed approximately one
hour before
sexual activity. Based on efficacy and tolerability, the dose
may be increased to
100mg or decreased to 25mg. The maximum recommended dose is 100
mg. The
maximum recommended dosing frequency is once
per day. If Sildenafil is taken with
food, the onset of activity may be delayed
compared to the fasted state (see Section
5.2).
_Special populations _
_ _
ELDERLY PATIENTSDosage adjustments are not
required in elderly patients (
≥ 65 years
old)..
PATIENTS WITH RENAL IMPAIRMENT The dosing recommendations
described in “Use in
adults” apply to patients with mild
to moderate renal impairment (creatinine clearance
= 30-80 ml/min).
Since sildenafil clearance is reduced in patients with severe
renal im
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